BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OVER-THE-WIRE PTCA CATHETER

    MDR report key: 1111626 · Received August 13, 2008

    Report

    Report Number
    2134265-2008-02313
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS CONFIRMED THE BALLOON BURST STATED IN THE COMPLAINT. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE AND BLOOD WAS PRESENT IN THE BALLOON. THE DEVICE WAS INFLATED AND A PINHOLE WAS LOCATED IN THE MIDDLE OF THE PROXIMAL MARKERBAND LOCATION. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE DAMAGE DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS NOT POSSIBLE TO DETERMINE EXACTLY HOW OR WHEN THE DAMAGE OCCURRED. IT SHOULD BE NOTED THAT THERE WAS NO EVIDENCE OF MANUFACTURING DEFECT OR ANOMALY WITHIN THE MANUFACTURING RECORDS REVIEWED FOR THE REPORTED BATCH. THE MOST PROBABLE ROOT CAUSE WILL BE CONSIDERED OPERATIONAL CONTEXT, DUE TO THE LIKELIHOOD THAT THE REPORTED DAMAGE IS ATTRIBUTABLE TO PROCEDURAL FACTORS AND/OR INTERACTION WITH PT ANATOMY OR OTHER DEVICES, AND DUE TO THE LACK OF EVIDENCE INDICATING A DEVICE RELATED ROOT CAUSE. THERE IS NO EVIDENCE OF ANY MATERIAL, MANUFACTURING, OR PERFORMANCE SPECIFICATION NON-CONFORMANCES RELEGATED TO THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-02314. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN A HEAVILY CALCIFIED VESSEL. A 3.0X12MM MAVERICK BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 8 ATMS WHEN IT RUPTURED. A 3.0X12MM QUANTUM MAVERICK BALLOON WAS ALSO USED DURING THIS PROCEDURE AND RUPTURED AT 10 ATMS. THE PROCEDURE WAS COMPLETED WITH A CUTTING BALLOON AND A 2.5X12MM TAXUS EXPRESS2 STENT WAS PLACED. NO PT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OVER-THE-WIRE PTCA CATHETER LOX, CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY LOX BOSTON SCIENTIFIC 12/3.0 11706082

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR